81 FR 6869 - Independent Assessment of the Process for the Review of Device Submissions; Implementation Evaluation Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 26 (February 9, 2016)

Page Range		6869-6869
FR Document		2016-02545

The Food and Drug Administration (FDA or Agency) is announcing Booz Allen Hamilton's final evaluation report submitted as part of their independent assessment of the process for the review of medical device submissions. The evaluation is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 through 2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III Commitment Letter). The evaluation has been conducted as the second phase (Phase 2) and is the last of a series of deliverables, as outlined in the contract statement of work.

Federal Register, Volume 81 Issue 26 (Tuesday, February 9, 2016)

[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Page 6869]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02545]



[[Page 6869]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1504]


Independent Assessment of the Process for the Review of Device 
Submissions; Implementation Evaluation Report

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
Booz Allen Hamilton's final evaluation report submitted as part of 
their independent assessment of the process for the review of medical 
device submissions. The evaluation is part of the FDA performance 
commitments relating to the Medical Device User Fee Amendments of 2012 
(MDUFA III), which reauthorized device user fees for fiscal years 2013 
through 2017. The assessment is described in section V, Independent 
Assessment of Review Process Management, of the commitment letter 
entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III 
Commitment Letter). The evaluation has been conducted as the second 
phase (Phase 2) and is the last of a series of deliverables, as 
outlined in the contract statement of work.

FOR FURTHER INFORMATION CONTACT: Raphaela Simon, Office of Planning, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
3379, Silver Spring, MD 20993-0002, 301-796-9169, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, President Obama signed into law the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA).\1\ 
Title II of FDASIA is the Medical Device User Fee Amendments of 2012 
(MDUFA III), which gives FDA the authority to collect device user fees 
from industry for fiscal years 2013 through 2017. MDUFA III took effect 
on October 1, 2012, and will continue through September 30, 2017.
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    \1\ https://www.thefederalregister.org/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf.
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    Device user fees were first established by Congress in 2002. 
Medical device companies pay fees to FDA when they register their 
establishment and list their devices with the Agency, whenever they 
submit an application or a notification to market a new medical device 
in the United States, and for certain other types of submissions. Under 
MDUFA III, FDA is authorized to collect user fees that will total 
approximately $595 million (plus adjustments for inflation) over 5 
years. With this additional funding, FDA will be able to hire more than 
200 full-time-equivalent workers over the course of MDUFA III. In 
exchange, FDA has committed to meet certain performance goals outlined 
in the MDUFA III Commitment Letter.\2\
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    \2\ www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
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II. Assessment of FDA's Process for the Review of Device Submissions

    Section V of the MDUFA III Commitment Letter states that FDA and 
the device industry will participate in a comprehensive assessment of 
the process for the review of device applications. The assessment will 
include consultation with both FDA and industry. The assessment will be 
conducted in two phases by a private, independent consulting firm, 
under contract with FDA, that is capable of performing the technical 
analysis, management assessment, and program evaluation tasks required 
to address the assessment as described in the MDUFA III Commitment 
Letter.
    FDA awarded the contract in June 2013 to the consulting firm Booz 
Allen Hamilton. Findings on high-priority recommendations (i.e., those 
likely to have a significant impact on review times) were published in 
December 2013.\3\ Final comprehensive findings and recommendations were 
scheduled to be published within 1 year of the contract award and are 
included in the report available at www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM426392.pdf. FDA agreed to publish an 
implementation plan within 1 year of the final findings and 
recommendations. The final implementation plan, ``Plan of Action,'' was 
published December 2014 and is available at www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM426392.pdf. Examination of 
the final comprehensive findings and recommendations report led FDA to 
conclude that the recommendations could be expanded to further enhance 
the efficiency of premarket reviews. Those actions were also outlined 
in the Plan of Action. To distinguish actions in direct response to the 
recommendations from additional actions to further improve the 
premarket review process, FDA used a ``Stage'' approach. In the Plan of 
Action ``Stage 1'' actions directly addressed the recommendations in 
the independent assessment and ``Stage 2'' actions outlined additional 
long-term actions the Agency intended to implement to further enhance 
the premarket review process. In addition, FDA has publicly stated in 
the ``Plan of Action'' that the Agency intended to complete all Stage 1 
actions by December 31, 2015.
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    \3\ www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM378202.pdf.
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    For Phase 2 of the independent assessment, the contractor evaluated 
the implementation of recommendations, described under Stage 1 in the 
``Plan of Action,'' and is publishing its written assessment \4\ no 
later than February 1, 2016.
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    \4\ http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM484146.pdf.
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    FDA has implemented all Stage 1 actions outlined in the Plan of 
Action, and incorporated the resulting enhancements into the management 
of the premarket review program. Resources permitting, the Center for 
Devices and Radiological Health will continue to implement Stage 2 
actions. FDA will monitor implemented improvements for accomplishment 
of intended results and the process for the review of device 
submissions for additional improvement opportunities.

    Dated: February 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02545 Filed 2-8-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 6869

DEPARTMENT OF HEALTH AND types of submissions. Under MDUFA III, recommendations in the independent
HUMAN SERVICES FDA is authorized to collect user fees assessment and ‘‘Stage 2’’ actions
that will total approximately $595 outlined additional long-term actions
Food and Drug Administration million (plus adjustments for inflation) the Agency intended to implement to
[Docket No. FDA–2013–N–1504] over 5 years. With this additional further enhance the premarket review
funding, FDA will be able to hire more process. In addition, FDA has publicly
Independent Assessment of the than 200 full-time-equivalent workers stated in the ‘‘Plan of Action’’ that the
Process for the Review of Device over the course of MDUFA III. In Agency intended to complete all Stage
Submissions; Implementation exchange, FDA has committed to meet 1 actions by December 31, 2015.
Evaluation Report certain performance goals outlined in For Phase 2 of the independent
the MDUFA III Commitment Letter.2 assessment, the contractor evaluated the
AGENCY: Food and Drug Administration, implementation of recommendations,
HHS. II. Assessment of FDA’s Process for the
described under Stage 1 in the ‘‘Plan of
ACTION: Notice. Review of Device Submissions
Action,’’ and is publishing its written
Section V of the MDUFA III assessment 4 no later than February 1,
SUMMARY: The Food and Drug Commitment Letter states that FDA and 2016.
Administration (FDA or Agency) is the device industry will participate in a FDA has implemented all Stage 1
announcing Booz Allen Hamilton’s final comprehensive assessment of the actions outlined in the Plan of Action,
evaluation report submitted as part of process for the review of device and incorporated the resulting
their independent assessment of the applications. The assessment will enhancements into the management of
process for the review of medical device include consultation with both FDA and the premarket review program.
submissions. The evaluation is part of industry. The assessment will be Resources permitting, the Center for
the FDA performance commitments conducted in two phases by a private, Devices and Radiological Health will
relating to the Medical Device User Fee independent consulting firm, under continue to implement Stage 2 actions.
Amendments of 2012 (MDUFA III), contract with FDA, that is capable of FDA will monitor implemented
which reauthorized device user fees for performing the technical analysis, improvements for accomplishment of
fiscal years 2013 through 2017. The management assessment, and program intended results and the process for the
assessment is described in section V, evaluation tasks required to address the review of device submissions for
Independent Assessment of Review assessment as described in the MDUFA additional improvement opportunities.
Process Management, of the III Commitment Letter.
commitment letter entitled ‘‘MDUFA Dated: February 4, 2016.
FDA awarded the contract in June
Performance Goals and Procedures’’ 2013 to the consulting firm Booz Allen Leslie Kux,
(MDUFA III Commitment Letter). The Hamilton. Findings on high-priority Associate Commissioner for Policy.
evaluation has been conducted as the recommendations (i.e., those likely to [FR Doc. 2016–02545 Filed 2–8–16; 8:45 am]
second phase (Phase 2) and is the last have a significant impact on review BILLING CODE 4164–01–P
of a series of deliverables, as outlined in times) were published in December
the contract statement of work. 2013.3 Final comprehensive findings
FOR FURTHER INFORMATION CONTACT: and recommendations were scheduled DEPARTMENT OF HEALTH AND
Raphaela Simon, Office of Planning, to be published within 1 year of the HUMAN SERVICES
Food and Drug Administration, 10903 contract award and are included in the
New Hampshire Ave., Bldg. 32, Rm. report available at www.fda.gov/ Food and Drug Administration
3379, Silver Spring, MD 20993–0002, downloads/ForIndustry/UserFees/ [Docket No. FDA–2016–D–0270]
301–796–9169, Raphaela.Simon@ MedicalDeviceUserFee/UCM426392.pdf.
fda.hhs.gov. FDA agreed to publish an Display Devices for Diagnostic
implementation plan within 1 year of Radiology; Draft Guidance for Industry
SUPPLEMENTARY INFORMATION:
the final findings and recommendations. and Food and Drug Administration
I. Background The final implementation plan, ‘‘Plan of Staff; Availability
On July 9, 2012, President Obama Action,’’ was published December 2014 AGENCY: Food and Drug Administration,
signed into law the Food and Drug and is available at www.fda.gov/ HHS.
Administration Safety and Innovation downloads/ForIndustry/UserFees/
MedicalDeviceUserFee/UCM426392.pdf. ACTION: Notice.
Act (Pub. L. 112–144) (FDASIA).1 Title
II of FDASIA is the Medical Device User Examination of the final comprehensive SUMMARY: The Food and Drug
Fee Amendments of 2012 (MDUFA III), findings and recommendations report Administration (FDA or Agency) is
which gives FDA the authority to collect led FDA to conclude that the announcing the availability of the draft
device user fees from industry for fiscal recommendations could be expanded to guidance entitled ‘‘Display Devices for
years 2013 through 2017. MDUFA III further enhance the efficiency of Diagnostic Radiology’’. This draft
took effect on October 1, 2012, and will premarket reviews. Those actions were guidance document provides
continue through September 30, 2017. also outlined in the Plan of Action. To recommendations for the types of
Device user fees were first established distinguish actions in direct response to information you should provide in your
by Congress in 2002. Medical device the recommendations from additional premarket notification submission
companies pay fees to FDA when they actions to further improve the premarket (510(k)) for display devices intended for
mstockstill on DSK4VPTVN1PROD with NOTICES

register their establishment and list their review process, FDA used a ‘‘Stage’’ diagnostic radiology with the assigned
devices with the Agency, whenever they approach. In the Plan of Action ‘‘Stage product code PGY. This guidance, when
submit an application or a notification 1’’ actions directly addressed the finalized, will replace a previously
to market a new medical device in the 2 www.fda.gov/downloads/MedicalDevices/News
issued final guidance entitled ‘‘Display
United States, and for certain other Events/WorkshopsConferences/UCM295454.pdf. Accessories for Full-Field Digital
3 www.fda.gov/downloads/MedicalDevices/Device
1 https://www.gpo.gov/fdsys/pkg/PLAW- RegulationandGuidance/Overview/MDUFAIII/ 4 http://www.fda.gov/downloads/ForIndustry/

112publ144/pdf/PLAW-112publ144.pdf. UCM378202.pdf. UserFees/MedicalDeviceUserFee/UCM484146.pdf.

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Document Created: 2018-02-02 14:30:21
Document Modified: 2018-02-02 14:30:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Raphaela Simon, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3379, Silver Spring, MD 20993-0002, 301-796-9169, [email protected]
FR Citation		81 FR 6869

81 FR 6869 - Independent Assessment of the Process for the Review of Device Submissions; Implementation Evaluation Report

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 26 (February 9, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration